The In vitro diagnostics Medical Device Directive 98/79/EC
The scope of 98/79/EC applies to IVD medical devices and accessories, which can include not just reagents and kits but also instruments and software. Article 1 of 98/79/EC gives the legal definitions which confirm that IVDs are a specific category of medical devices with particular differences and are therefore controlled under this separate Directive. The definitions mentioned in the In vitro diagnostics Medical Device Directive is stated as follow:
“Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
- concerning a physiological or pathological state, or
- concerning a congenital abnormality, or
- to determine the safety and compatibility with potential recipients, or
- to monitor therapeutic measures.”
This directive 98/79/EC has to apply to the whole spectrum of IVDs, it does not define specific technical factors but instead identifies broad based essential safety requirements to be met by all devices.
The risk and intended use and properties associated with a device determines the classification, and therefore the level of control and review that’s necessary. The In Vitro Medical Device Directive groups devices into four categories.
- Other/General Device:
all devices except those mentioned in Annex II and self-testing devices;
Annex II is a chapter in the Directive and is sub-divided into two lists, List A and List B. All Annex II IVD’s require the involvement of a Notified Body before the product can be placed on the market
- Device for Self-Testing (not listed in Annex II):
a device intended by the manufacturer to be able to be used by a person in a home environment, excluding self-test devices covered in Annex II;
- Device of List B, Annex II:
This category includes reagents and products for rubella, toxoplasmosis and phenylketonuria as well as devices for self-testing for blood sugar;
- Device of List A, Annex II
The last category includes reagents and products for human immunodeficiency virus I and II, hepatitis B, C and D.